Search
Close this search box.

Remuneration of donors for cell and gene therapies: an update on the principles and perspective of the World Marrow Donor Association – Bone Marrow Transplantation

  • Alliance for Regenerative Medicine. Available Products: a comprehensive list of current cell and gene therapy products available in different markets across the world. 2022 [cited 2023]. Available from: https://alliancerm.org/available-products/.

  • United States Food and Drug Administration. Cellular & Gene Therapy Products 2022. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products.

  • European Medicines Agency. Advanced therapy medicinal products: Overview 2022. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview.

  • UK Government. Donation of Starting Material for Advanced Cell-Based Therapies [Internet]. 2014 July 04 [cited 2023 Jul 16]. Available from: https://www.gov.uk/government/publications/donation-of-starting-material-for-advanced-cell-based-therapies.

  • European Medicines Agency. Accelerated Asssessment 2022 [cited 2023]. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment.

  • FDA. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions [Internet]. 2019 May 16 [cited 2023 Jul 16]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious-conditions.

  • Alliance for Regenerative Medicine (ARM). ARM H1 2022 Report [Internet]. 2022 September [cited 2023 Jul 16]. Available from: https://alliancerm.org/wp-content/uploads/2022/09/ARM-H1-2022-R11.pdf.

  • Lysaght T. Accelerating regenerative medicine: the Japanese experiment in ethics and regulation. Regen Med. 2017;12:657–68.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Cuende N, Rasko JEJ, Koh MBC, Dominici M, Ikonomou L. Cell, tissue and gene products with marketing authorization in 2018 worldwide. Cytotherapy. 2018;20:1401–13.

    Article 
    PubMed 

    Google Scholar
     

  • European Commission. Economic landscapes of human tissues and cells for clinical application in the EU. [Internet]. 2015 [cited 2023 Jul 16]. Available from: https://publications.europa.eu/resource/cellar/5a0fd429-4a4e-11e6-9c64-01aa75ed71a1.0001.02/DOC_1.

  • Saez-Ibanez AR, Upadhaya S, Partridge T, Shah M, Correa D, Campbell J. Landscape of cancer cell therapies: trends and real-world data. Nat Rev Drug Discov. 2022;21:631–2.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Caldwell KJ, Gottschalk S, Talleur AC. Allogeneic CAR cell therapy-more than a pipe dream. Front Immunol. 2020;11:618427.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Qasim W. Allogeneic CAR T cell therapies for leukemia. Am J Hematol. 2019;94:S50–S4.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Riva L, Resta G, Gambino A, Petrini C. Donation of human biological materials in the European Union: commodifying solidarity in the era of the biotechnological revolution? N Bioeth. 2019;25:349–58.

    Article 

    Google Scholar
     

  • Boo M, van Walraven SM, Chapman J, Lindberg B, Schmidt AH, Shaw BE, et al. Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association. Blood. 2011;117:21–5.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Nuffield Council on Bioethics. Human bodies: donation for medicine and research. 2011 Oct 10 [cited 2023 Jul 16]. Available from: https://www.nuffieldbioethics.org/publications/human-bodies-donation-for-medicine-and-research.

  • Iglesias-Lopez C, Agusti A, Obach M, Vallano A. Regulatory framework for advanced therapy medicinal products in Europe and the United States. Front Pharm. 2019;10:921.

    Article 
    CAS 

    Google Scholar
     

  • FDA. Cellular & Gene Therapy Guidances [Internet]. 2023 [cited 2023 May 16]. Available from: https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances.

  • Cohen IG. Selling bone marrow—Flynn v. Holder. N Engl J Med. 2012;366:296–7.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Todd K. Hope for to-marrow: the status of paid peripheral blood stem cell donation under the National Organ Transplant Act. J Law Biosci. 2017;4:412–23.

    Article 

    Google Scholar
     

  • European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 [Internet]. 2004 Mar 31 [cited 2023 Jul 16]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004L0023.

  • Alliance for Regenerative Medicine. Regulatory Analysis, Final Report [Internet]. 2019 July 09 [cited 2023 Jul 20]. Available from: https://alliancerm.org/wp-content/uploads/2019/09/IQVIA-ARM-EU-US-Regulatory-Analysis-Final-Report-0710193.pdf.

  • Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. [Internet]. 2016 [cited 2023 Jul 12]. Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.

  • European Commission. Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. [Internet]. 2022 July 14 [cited 2023 Oct 28]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0338.

  • EURACTIV. Parliament Mulls Broad Stakeholder Access to Key EU Body in New Human Substances Rules [Internet]. 2023 Apr 27 [cited 2023 Jul 15]. Available from: https://www.euractiv.com/section/health-consumers/news/parliament-mulls-broad-stakeholder-access-to-key-eu-body-in-new-human-substances-rules/.

  • United Kingdom. Human Tissue (Quality and Safety for Human Application) Regulations 2007 [Internet]. 2007 [cited 2023 May 10]. Available from: https://www.legislation.gov.uk/uksi/2007/1523/contents/made.

  • Cell Sourcing for Research and GMP Human Cells Charles River website. Available from: https://www.criver.com/products-services/cell-sourcing.

  • Primary and Stem Cells Lonza website. Available from: https://bioscience.lonza.com/lonza_bs/GB/en/Catalogue/Products/Primary-and-Stem-Cells/c/2?q=%3A%3A%3A%3Alonza-sort%3A%3A%3A%3Alon_cl_PrimaryCellType%3A%3A%3A%3AWhole+Bone+Marrow.

  • Ministry of Health Singapore. A Guide to the Prohibition Against Commercial Trading of Human Tissue: Human Biomedical Research Act- February 2017 [Internet]. 2017 Feb [cited 2023 May 10]. Available from: https://www.moh.gov.sg/docs/librariesprovider5/legislation/guidance-on-prohibition-against-commercial-trading-of-human-tissue-under-hbra—february-2017.pdf.

  • World Health Organization. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Cell Tissue Bank. 2010 Nov;11(4):413–9.

  • Department of Health and Human Services. Removing Financial Disincentives to Living Organ Donation. 42 CFR Part 121. RIN 0906-AB23 [Internet]. 2020 Sept 22 [cited 2023 May 10]. Available from: https://www.federalregister.gov/d/2020-20804.

  • CGT Clinics. Donor Compensation Online 2023. Available from: https://cgt.global/donate-blood/blood-donor-compensation/.

  • Hemacare Donor Center. Donation Process Online. Available from: https://www.hemacaredonorcenter.com/donation-process.

  • LeukoLab. Donate Blood for Research. Available from: https://www.leukolab.com/.

  • European Commission Directorate-General for Research and Innovation. Ethics for Researchers. 2013. Available from: https://data.europa.eu/doi/10.2777/7491.

  • Rosenmayr A, Hartwell L, Egeland T. Ethics Working Group of the World Marrow Donor A. Informed consent—suggested procedures for informed consent for unrelated haematopoietic stem cell donors at various stages of recruitment, donor evaluation, and donor workup. Bone Marrow Transpl. 2003;31:539–45.

    Article 
    CAS 

    Google Scholar
     

  • Holig K, Kramer M, Kroschinsky F, Bornhauser M, Mengling T, Schmidt AH, et al. Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors. Blood. 2009;114:3757–63.

    Article 
    PubMed 

    Google Scholar
     

  • Loper K, Sugrue MW, Raval JS, Schwartz JY, Land K, Koh M, et al. Adverse event reporting for cellular therapy products: current status and future directions. Transfusion. 2020;60:2815–27.

    Article 
    PubMed 

    Google Scholar
     

  • Lensink MA, Jongsma KR, Boers SN, Bredenoord AL. Better governance starts with better words: why responsible human tissue research demands a change of language. BMC Med Ethics. 2022;23:90.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • The European Committee On Organ Transplantation of the Council of Europe. Risk of Commodification of Substances of Human Origin: A Position Statement of The European Committee On Organ Transplantation of the Council of Europe November 18, 2022. [Internet]. 2022 Nov 18 [cited 2023 June 20]. Available from: Available from: https://www.edqm.eu/documents/52006/0/OTC-CD-P-TO-Position-statement-Risk-of-commodification-of-SoHO-2022-11-18-Final.pdf/79e289b0-a02e-d3db-60c9-b9110ef704f2?t=1669631797556.

  • Ogbogu U, Rachul C, Caulfield T. Reassessing direct-to-consumer portrayals of unproven stem cell therapies: is it getting better? Regen Med. 2013;8:361–9.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Turner L. US stem cell clinics, patient safety, and the FDA. Trends Mol Med. 2015;21:271–3.

    Article 
    PubMed 

    Google Scholar
     

  • Turner L, Knoepfler P. Selling stem cells in the USA: assessing the direct-to-consumer industry. Cell Stem Cell. 2016;19:154–7.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • United States Food and Drug Administration. FDA Warns About Stem Cell Therapies 2019. Available from: https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies.

  • European Medicines Agency. EMA warns against using unproven cell-based therapies 2020. Available from: https://www.ema.europa.eu/en/documents/public-statement/ema-warns-against-using-unproven-cell-based-therapies_en.pdf.

  • Master Z, Matthews KRW, Abou-El-Enein M. Unproven stem cell interventions: a global public health problem requiring global deliberation. Stem Cell Rep. 2021;16:1435–45.

    Article 

    Google Scholar
     

  • Chell K, Davison TE, Masser B, Jensen K. A systematic review of incentives in blood donation. Transfusion. 2018;58:242–54.

    Article 
    PubMed 

    Google Scholar
     

  • Bambrick H, Gallego G. Community attitudes to remunerated blood donation in Australia: results from a national telephone survey. Transfus Med. 2013;23:302–8.

    Article 
    PubMed 

    Google Scholar
     

  • France CR, France JL, Himawan LK. What would it take to convince you to donate? A survey study of the relationship between motivators, barriers, and payment for whole blood, plasma, and platelet donation. Transfusion. 2022;62:1251–60.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Liao G, Gilmore K, Steed A, Elmoazzen H, Allan DS. Willingness of volunteers from Canadian Blood Service’s Stem Cell Registry to donate blood, marrow, and other tissues for regenerative therapy. Transfusion. 2020;60:582–7.

    Article 
    PubMed 

    Google Scholar
     

  • Hamad L, Anthias C, Gibson D, O’Leary A, Machin L. Prospective donors’ perspectives on hematopoietic cell donation for cell and gene therapy research and development. Regen Med. 2023;18:301–11.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Hamad L, Anthias C, Machin L. How do we forecast tomorrow’s transfusion: The future of hematopoietic stem cell donation. Transfus Clin Biol. 2023;30:52–55. https://doi.org/10.1016/j.tracli.2022.11.002.

  • Niza C, Tung B, Marteau TM. Incentivizing blood donation: systematic review and meta-analysis to test Titmuss’ hypotheses. Health Psychol. 2013;32:941–9.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Bruers S. Blood donation and monetary incentives: a meta-analysis of cost-effectiveness. Transfus Med Rev. 2022;36:48–57.

    Article 
    PubMed 

    Google Scholar
     

  • Confer DL, Shaw BE, Pamphilon DH. Clinical Working Group of the W. WMDA guidelines for subsequent donations following initial BM or PBSCs. Bone Marrow Transpl. 2011;46:1409–12.

    Article 
    CAS 

    Google Scholar
     

  • German Bone Marrow Donor Center DKMS. DKMS Operational User Guide [Internet]. 2023 [cited 2023 June 20]. Available from: https://assets-eu-01.kc-usercontent.com/4363e450-c34d-01ec-bbc1-f778b28d38e2/eb3347f8-ff62-43f7-a9ae-c19d57782d75/DKMS%20Operational%20User%20Guide%20V3.0%20-%20valid%20as%20of%202024-01-01.pdf.

  • Shaw BE, Ball L, Beksac M, Bengtsson M, Confer D, Diler S, et al. Donor safety: the role of the WMDA in ensuring the safety of volunteer unrelated donors: clinical and ethical considerations. Bone Marrow Transpl. 2010;45:832–8.

    Article 
    CAS 

    Google Scholar
     

  • Bakken R, van Walraven AM, Egeland T. Ethics Working Group of the World Marrow Donor A. Donor commitment and patient needs. Bone Marrow Transpl. 2004;33:225–30.

    Article 
    CAS 

    Google Scholar
     

  • Egeland T, Lie J, Persson U, Raymond J, Muller C, World Marrow Donor Association Ethics Working G. Donor and liability insurance of donor registries, donor centers, and collection centers—recommendations. Bone Marrow Transpl. 2004;33:467–70.

    Article 
    CAS 

    Google Scholar
     

  • van Walraven SM, Egeland T, Borrill V, Nicoloso-de Faveri G, Rall G. Addressing ethical and procedural principles for unrelated allogeneic hematopoietic progenitor cell donation in a changing medical environment. Biol Blood Marrow Transpl. 2018;24:887–94.


    Google Scholar
     

  • Pirnay JP, Baudoux E, Cornu O, Delforge A, Delloye C, Guns J, et al. Access to human tissues for research and product development: from EU regulation to alarming legal developments in Belgium. EMBO Rep. 2015;16:557–62.

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Dismay for UK myeloma patients as Carvykti launch is slowed The Pharmaletter 2023. Available from: https://www.thepharmaletter.com/article/dismay-for-british-myeloma-patients-as-carvykti-launch-is-slowed.

  • Obenshain A. bluebird bio Community Update Bluebird bio2021. Available from: https://www.bluebirdbio.com/-/media/bluebirdbio/Corporate-COM/Files/bbbcom-community-update-letter.pdf.

  • The World Marrow Donor Association. What We Do 2023. Available from: https://wmda.info/about-us/what-we-do/.

  • Catherine Eckford. World’s first approval of an allogeneic T-cell immunotherapy European Pharmaceutical Review 2022. Available from: https://www.europeanpharmaceuticalreview.com/news/177795/worlds-first-approval-of-an-allogeneic-t-cell-immunotherapy/.

  • Alliance for Regenerative Medicine. The Sector Snapshot 2023. Available from: https://alliancerm.org/sector-snapshot/.